Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mucinex® Fast-Max® Day Time Severe Cold and Mucinex® Fast-Max® Night Time Cold and Flu Maximum Strength

Drug Facts

Active ingredients (in each caplet)

Purposes

Mucinex FAST-MAX DAY TIME Severe Cold

Acetaminophen 325 mg

Pain reliever/fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

Active ingredients (in each caplet)

Purposes

Mucinex FAST-MAX NIGHT TIME Cold & Flu

Acetaminophen 325 mg

Pain reliever/fever reducer

Diphenhydramine HCl 25 mg

Antihistamine

Phenylephrine HCl 5 mg

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

nasal congestion

cough (Mucinex FAST-MAX DAY TIME Severe Cold only)

minor aches and pains

headache

sore throat

runny nose and sneezing (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex FAST-MAX DAY TIME Severe Cold only)

temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 12 caplets in 24 hours, which is the maximum daily amount

with other drugs that contain acetaminophen

3 or more alcoholic drinks daily while using this product

Sore throat warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

with any other drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

pain, nasal congestion, or cough gets worse, or lasts more than 7 days

fever gets worse, or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back, or occurs with fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see Overdose warning)

do not take more than 12 caplets in any 24-hour period

adults and children 12 years of age and older: take 2 caplets every 4 hours

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.